Description: Foundational knowledge related to the quality management system.

Terminal Competency:

Explain laboratory quality management systems.

Enabling Competencies:

1. Explain the importance of a quality management system.

2. Identify the principles of a quality management system.

3. Explain the relationship between accreditation and a quality management system.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Components of the quality management system.

Terminal Competency:

Describe the components of the quality management system.

Enabling Competencies:

1. Identify the importance of technical review.

2. Apply document control requirements.

3. Describe the process of reporting non-conforming work as non-conformance.

4. Locate quality management documents.

5. Describe training requirements for competency.

6. Recognize the importance of the quality manual to the laboratory work.

7. Describe the corrective action process.

8. Identify the need for a root cause analysis.

9. Describe the risk management process.

10. Describe the importance of quality control.

11. Describe the internal audit process.

12. Describe the use of a proficiency sample.

13. Define traceability.

14. Explain the importance of using validated methodology.

15. Explain the importance of using calibrated equipment.

16. Recognize the need to use only approved supplies.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.